Sam Brusco, Associate Editor03.20.24
Medtronic has received Health Canada approval for its Symplicity Spyral multi-electrode renal denervation (RDN) system.
The Symplicity blood pressure procedure is a minimally invasive approach that uses radiofrequency (RF) ablation to calm the nerves near the kidneys, which can become overactive and contribute to high blood pressure. The technology is indicated to manage essential hypertension in those whose blood pressure remains uncontrolled despite lifestyle modifications and guideline-driven therapy with antihypertensive medications.
The Health Canada license was based on clinical evidence in over 25,000 patients globally. Patients’ office systolic blood pressure was found to be reduced by over 9 mmHg at three to six months, over 18 mmHg at three years, and sustained blood pressure reduction at three years in over 1,500 patients, according to Medtronic data.
The procedure also showed better blood pressure control with more time in treatment range after RF RDN when compared to sham through three years. Symplicity Spyral earned U.S. Food and Drug Administration (FDA) approval in 2023 and is approved for commercial use in over 70 countries.
“As we look to improve options to help manage patients with hypertension, we’re encouraged by this latest approval of the Symplicity Spyral renal denervation system,” said Dr. Sheldon Tobe, nephrologist and hypertension specialist, Sunnybrook Health Sciences Centre. “There is a big unmet need in Canada for the subset of patients who can’t fully control hypertension with medication and/or lifestyle changes. This innovative procedure will help to fill that gap by potentially helping to improve blood pressure control.”
“As the pioneer in renal denervation, we are looking forward to making a difference for hypertension patients in Canada,” said Maisie Cheung, director of marketing, Medtronic Canada. “This means more choices for patients—and offers physicians an adjunctive option along with lifestyle changes and medications to help manage patients with high blood pressure.”
The Symplicity blood pressure procedure is a minimally invasive approach that uses radiofrequency (RF) ablation to calm the nerves near the kidneys, which can become overactive and contribute to high blood pressure. The technology is indicated to manage essential hypertension in those whose blood pressure remains uncontrolled despite lifestyle modifications and guideline-driven therapy with antihypertensive medications.
The Health Canada license was based on clinical evidence in over 25,000 patients globally. Patients’ office systolic blood pressure was found to be reduced by over 9 mmHg at three to six months, over 18 mmHg at three years, and sustained blood pressure reduction at three years in over 1,500 patients, according to Medtronic data.
The procedure also showed better blood pressure control with more time in treatment range after RF RDN when compared to sham through three years. Symplicity Spyral earned U.S. Food and Drug Administration (FDA) approval in 2023 and is approved for commercial use in over 70 countries.
“As we look to improve options to help manage patients with hypertension, we’re encouraged by this latest approval of the Symplicity Spyral renal denervation system,” said Dr. Sheldon Tobe, nephrologist and hypertension specialist, Sunnybrook Health Sciences Centre. “There is a big unmet need in Canada for the subset of patients who can’t fully control hypertension with medication and/or lifestyle changes. This innovative procedure will help to fill that gap by potentially helping to improve blood pressure control.”
“As the pioneer in renal denervation, we are looking forward to making a difference for hypertension patients in Canada,” said Maisie Cheung, director of marketing, Medtronic Canada. “This means more choices for patients—and offers physicians an adjunctive option along with lifestyle changes and medications to help manage patients with high blood pressure.”